Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that acts by a
mechanism pioneered by Ironwood scientists. Linaclotide is marketed in
Researchers will present analyses of clinical data focusing on the safety and tolerability of linaclotide in the treatment of CIC and IBS-C, and on symptom improvement with linaclotide DR1 in IBS-C. An additional presentation will focus on the effect of stool consistency on bowel movement satisfaction with treatment of patients with IBS-C or CIC. The data will be presented via poster presentations as follows:
Bowel Movement Satisfaction in Patients with IBS-C or CIC:
Impact of Stool Consistency on Bowel Movement Satisfaction in IBS-C
or CIC Patients Treated With Linaclotide or Other Medications: Results
From the CONTOR Study (Abstract #P301), by Douglas C.A. Taylor,
Health Economics and Outcomes Research, Ironwood Pharmaceuticals, will be presented during a poster session on Sunday, October 15, 3:30 to 7:00 p.m.
Symptom Improvement with Linaclotide DR1 in IBS-C:
Effect of Linaclotide DR1, a Delayed-Release Formulation of
Linaclotide, in IBS-C Patients: Analysis of Symptom Improvement Using
Responder Radar Plots (Abstract #P1149), by
William D. Chey, M.D., F.A.C.G. Professorof Medicine, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, will be presented during a poster session on Monday, October 16, 10:30 a.m. to 4:00 p.m.
Pooled Analysis of Safety and Tolerability of Linaclotide for the Treatment of CIC and IBS-C:
Safety and Tolerability of Linaclotide for the Treatment of CIC and
IBS-C: A Pooled Analysis of Phase 3-3b Placebo-Controlled Trials in
North America(Abstract #P2020), by Judy Nee, M.D., Beth Israel Deaconess Medical Center, Boston, Massachusetts, will be presented during a poster session on Tuesday, October 17, 10:30 a.m. to 4:30 p.m.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that binds to the
GC-C receptor locally, within the intestinal epithelium, and is thought
to work in two ways, based on nonclinical studies. Activation of GC-C
results in increased intestinal fluid secretion and accelerated transit,
as well as a decrease in the activity of pain-sensing nerves in the
intestine. The clinical relevance of the effect on pain fibers, which is
based on nonclinical studies, has not been established. Linaclotide is
LINZESS INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS has not been established in patients less than 18 years of age.
LINZESS is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
Use of LINZESS should be avoided in pediatric patients 6 to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in < 1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC clinical trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs < 1%).
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